Ciprofloxacin (oral)

Ciprofloxacin (oral)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

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Overview

Ciprofloxacin (oral) is a antibiotic that is FDA approved for the treatment of urinary tract infections, chronic bacterial prostatitis, acute sinusitis, bone and joint infections, infectious diarrhea, typhoid fever. Common adverse reactions include rash, diarrhea, headache, cardiorespiratory arrest, photosensitivity, agranulocytosis, hepatic necrosis, tendinitis, raised intracranial pressure, retinal detachment, depression, acute renal failure.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• CIPRO is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations.

Adult Patients

• Urinary Tract Infections caused by Escherichia coli, Klebsiellapneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri (diversus), Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or vancomycin-susceptible Enterococcus faecalis.
• Acute Uncomplicated Cystitis in Females caused by Escherichia coli or Staphylococcus saprophyticus.
• Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis.
• Lower Respiratory Tract Infections caused by Escherichia coli, Klebsiellapneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or penicillin-susceptible Streptococcus pneumoniae.* Also, Moraxella catarrhalis for the treatment of acute exacerbations of chronic bronchitis.
• Ciprofloxacin is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.
• Acute Sinusitis caused by Haemophilusinfluenzae, penicillin-susceptible Streptococcus pneumoniae, or Moraxella catarrhalis.
• Skin and Skin Structure Infections caused by Escherichia coli, Klebsiellapneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providenciastuartii, Morganellamorganii, Citrobacterfreundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.
• Bone and Joint Infections caused by Enterobacter cloacae, Serratiamarcescens, or Pseudomonas aeruginosa.
• Complicated Intra-Abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiellapneumoniae, or Bacteroidesfragilis.
• Infectious Diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii†, Shigella dysenteriae, Shigella flexneri or Shigella sonnei† when antibacterial therapy is indicated.
• Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.

Typhoid Fever (Enteric Fever) caused by Salmonella typhi

• The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.
• Uncomplicated Cervical and Urethral Gonorrhea due to Neisseria gonorrhoeae.

Pediatric Patients (1 to 17 years of age)

• Complicated Urinary Tract Infections and Pyelonephritis due to Escherichia coli.
• Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues.
• Ciprofloxacin, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals.

Adult and Pediatric Patients

• Inhalational Anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.
• Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.5 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001.
• If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with CIPRO may be initiated before results of these tests are known; once results become available appropriate therapy should be continued.
• As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.
• To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO Tablets and CIPRO Oral Suspension and other antibacterial drugs, CIPRO Tablets and CIPRO Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
• When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• Safety and efficacy of extended-release ciprofloxacin (Cipro(R) XR) have not been established for treatment of infections other than UTIs.
• Immediate-release and extended-release oral dosage forms are not interchangeable.
• Patients initiated on ciprofloxacin IV therapy may be switched to oral ciprofloxacin when clinically indicated.
• A desensitization schedule for ciprofloxacin hypersensitivity has been developed by 1 institution.
• Bacteremia associated with intravascular line: (due to Ochrobacterium anthropi) 400 mg IV every 12 hours
• Bacterial meningitis: 800 to 1200 mg/day IV in divided doses every 8 to 12 hours
• Bacterial prostatitis, chronic: mild/moderate, 500 mg ORALLY every 12 hours for 28 days.
• Bacterial prostatitis, chronic: mild/moderate, 400 mg IV every 12 hours for 28 days.
• Bacterial sinusitis, acute: mild to moderate, 400 mg IV every 12 hours for 10 days.
• Bacterial sinusitis, acute: mild to moderate, 500 mg ORALLY every 12 hours for 10 days.
• Bronchitis, chronic, acute exacerbations: mild/moderate, 400 mg IV every 12 hours for 7 to 14 days.
• Bronchitis, chronic, acute exacerbations: mild/moderate, 500 mg ORALLY every 12 hours for 7 to 14 days.
• Bronchitis, chronic, acute exacerbations: severe/complicated, 400 mg IV every 8 hours for 7 to 14 days.
• Bronchitis, chronic, acute exacerbations: severe/complicated, 750 mg ORALLY every 12 hours for 7 to 14 days.
• Chancroid: 500 mg ORALLY twice a day for 3 days.
• Febrile neutropenia, Empiric therapy: 400 mg IV every 8 hours for 7 to 14 days, in combination with piperacillin 50 mg/kg IV every 4 hours (maximum 24 g/day) [2]
• Gonorrhea, Uncomplicated: 250 mg ORALLY as a single dose [6]; fluoroquinolones are no longer recommended by the CDC in the United States for the treatment of gonorrhea.
• Granuloma inguinale: 750 mg ORALLY twice daily for at least 21 days and lesions are healed completely.
• HIV infection - Salmonella gastroenteritis: (mild disease with or without symptomatic bacteremia) 500 to 750 mg ORALLY twice daily or 400 mg IV twice daily; duration of 7 to 14 days if CD4+ count is at least 200/mcL, 2 to 6 weeks if CD4+ count is less than 200/mcL, or at least 6 months for recurrent symptomatic septicemia
• Infection of bone - Infectious disorder of joint: mild/moderate, 400 mg IV every 12 hours for at least 4 to 6 weeks.
• Infection of bone - Infectious disorder of joint: mild/moderate, 500 mg ORALLY every 12 hours for at least 4 to 6 weeks.
• Infection of bone - Infectious disorder of joint: severe/complicated, 400 mg IV every 8 hours for at least 4 to 6 weeks.
• Infection of bone - Infectious disorder of joint: severe/complicated, 750 mg ORALLY every 12 hours for at least 4 to 6 weeks.

Infection of skin AND/OR subcutaneous tissue: mild/moderate, 400 mg IV every 12 hours for 7 to 14 days.

• Infection of skin AND/OR subcutaneous tissue: mild/moderate, 500 mg ORALLY every 12 hours for 7 to 14 days.
• Infection of skin AND/OR subcutaneous tissue: severe/complicated, 400 mg IV every 8 hours for 7 to 14 days.
• Infection of skin AND/OR subcutaneous tissue: severe/complicated, 750 mg ORALLY every 12 hours for 7 to 14 days.
• Infectious diarrheal disease: 500 mg orally every 12 hours for 5 to 7 days [6]
• Infectious disease of abdomen, Complicated: 400 mg IV every 12 hours for 7 to 14 days, in combination with metronidazole.
• Infectious disease of abdomen, Complicated: 500 mg ORALLY every 12 hours for 7 to 14 days, in combination with metronidazole.
• Infective endocarditis: (native valve, culture-negative) 500 mg ORALLY or 400 mg IV every 12 hours, in combination with vancomycin 15 mg/kg IV every 12 hours AND gentamicin sulfate 1 mg/kg IV/IM every 8 hours, for 4 to 6 weeks [9][10]
• Infective endocarditis: (prosthetic valve (late, greater than 1 year), culture-negative) 500 mg ORALLY or 400 mg IV every 12 hours, in combination with vancomycin 15 mg/kg IV every 12 hours AND gentamicin sulfate 1 mg/kg IV/IM every 8 hours, for 4 to 6 weeks AND rifampin 300 mg IV or ORALLY every 8 hours for 6 weeks.
• Infective endocarditis: (native and prosthetic valve endocarditis caused by HACEK microorganisms) 500 mg ORALLY or 400 mg IV every 12 hours for 4 to 6 weeks
• Inhalational anthrax, Postexposure; Prophylaxis: 400 mg IV every 12 hours for 60 days.
• Inhalational anthrax, Postexposure; Prophylaxis: 500 mg ORALLY every 12 hours for 60 days.
• Lower respiratory tract infection: mild/moderate, 400 mg IV every 12 hours for 7 to 14 days.
• Lower respiratory tract infection: mild/moderate, 500 mg ORALLY every 12 hours for 7 to 14 days.
• Lower respiratory tract infection: severe/complicated, 400 mg IV every 8 hours for 7 to 14 days.
• Lower respiratory tract infection: severe/complicated, 750 mg ORALLY every 12 hours for 7 to 14 days.
• Nosocomial pneumonia: 400 mg IV every 8 hours for 10 to 14 days.
• Pyelonephritis, acute, Uncomplicated: extended-release tablets (Cipro(R) XR), 1000 mg ORALLY once daily for 7 to 14 days [1]; clinical guidelines recommend a duration of 7 days for acute pyelonephritis
• Typhoid fever: 500 mg orally every 12 hours for 10 days.
• Urinary tract infectious disease, Severe or complicated: 400 mg IV every 8 to 12 hours for 7 to 14 days.
• Urinary tract infectious disease, Severe or complicated: immediate-release oral suspension, 500 mg ORALLY every 12 hours for 7 to 14 days.
• Urinary tract infectious disease, Severe or complicated: extended-release tablets (Cipro(R) XR), 1000 mg ORALLY once daily for 7 to 14 days.
• Urinary tract infectious disease, Uncomplicated: mild to moderate, 200 mg IV every 12 hours for 7 to 14 days.
• Urinary tract infectious disease, Uncomplicated: acute cystitis (oral suspension), 250 mg ORALLY every 12 hours for 3 days.
• Urinary tract infectious disease, Uncomplicated: mild/moderate (oral suspension), 250 mg ORALLY every 12 hours for 7 to 14 days.
• Urinary tract infectious disease, Uncomplicated: acute cystitis (extended-release tablets Cipro(R) XR), 500 mg ORALLY once daily for 3 days.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ciprofloxacin (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Ciprofloxacin (oral) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Ciprofloxacin (oral) in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ciprofloxacin (oral) in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Ciprofloxacin (oral) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Ciprofloxacin (oral) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ciprofloxacin (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ciprofloxacin (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ciprofloxacin (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Ciprofloxacin (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Ciprofloxacin (oral) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Ciprofloxacin (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ciprofloxacin (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ciprofloxacin (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ciprofloxacin (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ciprofloxacin (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ciprofloxacin (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Ciprofloxacin (oral) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Ciprofloxacin (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Ciprofloxacin (oral) in the drug label.

Pharmacology

There is limited information regarding Ciprofloxacin (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Ciprofloxacin (oral)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Ciprofloxacin (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Ciprofloxacin (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Ciprofloxacin (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Ciprofloxacin (oral) in the drug label.

How Supplied

Storage

There is limited information regarding Ciprofloxacin (oral) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Ciprofloxacin (oral) in the drug label.

Precautions with Alcohol

• Alcohol-Ciprofloxacin (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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